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Alemtuzumab · 1 trial · 1 indication
Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))
Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus.
| Arm | Type | Description |
|---|---|---|
| Alemtuzumab/Sirolimus | EXPERIMENTAL | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
| Alemtuzumab/Tacrolimus | EXPERIMENTAL | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
| Basiliximab/Tacrolimus | ACTIVE_COMPARATOR | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
| Basiliximab/Sirolimus | ACTIVE_COMPARATOR | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
| Name | Type | Description |
|---|---|---|
| Alemtuzumab | DRUG | Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart |
| Basiliximab | DRUG | 20 mg intravenously, two doses 96 hours apart |
| Sirolimus | DRUG | Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL |
| Tacrolimus | DRUG | Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization. |
Inclusion Criteria: * men or women aged over 18 years * recipient of kidney transplant (planned in next 24 hours) Exclusion Criteria: * recipients of multi-organ transplant * previous treatment with Campath-1H * active infection (including HIV, hepatitis B or C) * history of anaphylaxis to humani...
Alemtuzumab is being studied for use in kidney transplantation. It is an investigational small molecule being developed by Novartis AG. In clinical trials, it is being evaluated for its potential role in kidney transplant patients, specifically in the context of reducing calcineurin inhibitor use and addressing chronic allograft nephropathy.
Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes. By binding to CD52, it leads to the depletion of these cells, which is relevant in the context of transplantation to modulate the immune response. This mechanism is being explored in kidney transplantation to potentially improve graft outcomes.
Alemtuzumab is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in kidney transplantation.
Alemtuzumab is in Phase 2 clinical development for kidney transplantation. It is an investigational drug and has not yet been approved by regulatory authorities for this indication. The drug is still in clinical trials to assess its potential benefits and risks in this patient population.
Alemtuzumab has one completed clinical trial in kidney transplantation, identified by the NCT number NCT01120028. This Phase 2 trial, titled "Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy," enrolled 852 participants in the United Kingdom. The study was active-controlled and included adult patients aged 18 years and older.
Yes, Alemtuzumab is also known as Campath. In clinical trials for kidney transplantation, the study title references Campath, indicating that the drug is the same compound. This alternative name is used in the context of the clinical research being conducted by Novartis.